Examining a Common Complaint of Women Who Receive Chemotherapy for Breast Cancer- Cognitive Difficulty

Neurocognitive Impairment in Women With Early Stage Breast Cancer

This longitudinal project will investigate a common complaint of women who receive chemotherapy for breast cancer- cognitive difficulty. The relationships of fatigue, stress, and depression to cognitive difficulties will be examined. The findings should lead to interventions to decrease the effects of these problematic side effects.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breast Cancer; Neurocognitive Impairment
• Intervention / Treatment: Other: Neurocognitive impairment observation

Detailed Description

Most women with breast cancer are diagnosed in the early stages of the disease (Stage I and II) and 90% of these can expect to survive at least 5 years. Adjuvant chemotherapy regimens for breast cancer are often associated with complaints of cognitive changes, mostly the inability to concentrate and memory lapses that may persist in some women long after chemotherapy has ended. These changes are frequently accompanied by reports of a triad of behavioral conditions: fatigue, increased stress, and depressive symptoms. Biologically, cytokine release patterns play an important role in regulation of the immune system and normal CNS function, including neural cell repair and metabolism of neurotransmitters-both critical for normal cognitive functioning. Thus, the theoretical underpinnings of this research are embedded in the biobehavioral (mind-body) model which characterizes the multidimensional interactions among the mind, neuroendocrine, and immune systems. The purpose of this prospective, longitudinal project of 100 women is to determine whether there are differences in cognitive functioning and related behavioral conditions (fatigue, perceived stress, and depressive symptoms) in women in each of 3 groups: those with early stage BC treated with surgery and chemotherapy, women with early stage BC treated with surgery and without chemotherapy and an age-gender-education-matched healthy cohort without cancer. The primary aim of the project is to examine the relationships among fatigue, perceived stress, and depressive symptoms and neurocognitive impairment. A secondary aim is to explore the relationships among key behavioral and biological markers that may explain underlying mechanisms for development of neurocognitive impairment. In particular, this project will explore pro- and anti-inflammatory cytokine patterns and their potential associations with neurocognitive functioning. For the primary aim, the mixed linear model will be used to test for differences between the groups. For analysis of the secondary aim variable reduction stage and correlation will be used. The strength of this project is its biobehavioral approach to discerning underlying mechanisms of neurocognitive impairment in women with early stage BC receiving adjuvant chemotherapy. In addition, three other common behavioral conditions associated with BC and/or chemotherapy, fatigue, perceived stress, and depressive symptoms, will be evaluated for their potentially confounding effects on cognitive function.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virnigia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Participants in the two BC groups will be recruited from the Massey Cancer Center (MCC) clinical sites in Richmond, VA. Healthy volunteers will be recruited throughout the VCU Health System and through women's groups throughout the greater Richmond, VA area. The PI will provide physicians and clinical nurses an overview of the research and work with them to identify potential project participants. Participants will be provided oral and written information about the research and given an opportunity to ask questions or discuss the project with family or significant others.

Description

Inclusion Criteria:

• read and speak English
• be physically able to take the computerized test (press the keyboard space bar and numerical keys "1" and "2" without difficulty)
• have an ECOG Performance Status score < 2.154
• capable of providing informed consent.

Exclusion Criteria:

• psychiatric impairment, such as organic brain disorders, mental retardation, active psychoses or dissociative disorders, or unstable and/or severe depressive illness.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
women with stage I or II BC with adjuvant chemotherapy; women with Stage I or II BC who; have undergone surgical treatment (biopsy, lumpectomy or mastectomy) and;; will be receiving adjuvant chemotherapy	Other: Neurocognitive impairment observation; None - observational
women with Stage I or II BC without adjuvant therapy; Women with stage I or II BC who; Have undergone surgical treatment (biopsy, lumpectomy or mastectomy) \; will not be receiving adjuvant chemotherapy	Other: Neurocognitive impairment observation; None - observational
Healthy control; healthy education-age-matched women without cancer	Other: Neurocognitive impairment observation; None - observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
test neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms.	baseline
test for neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms.	4 months
test for neurocognitive function, using CNSVS, of the three groups while adjusting for fatigue, perceived stress, and depressive symptoms.	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
test level of inflammatory markers in order to explore the relationships between key behavioral and biological markers that may explain underlying mechanisms for development of neurocognitive impairment (NI).	baseline, month 4 and month 9

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Mary Jo Grapp, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 16, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Breast Cancer; Quality of Life; Cytokines; Neurocognitive Impairment
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 12321; 5P30NR011403 (U.S. NIH Grant/Contract)